Process Transfer Team Leaders

Challenging and varied jobs in our Process Transfer Department in Copenhagen as Process Transfer Team Leaders are open for colleagues with biopharmaceutical processing and leadership experience and a strong ability to drive interdepartmental collaboration. The Job:AGC Biologics continues to enjoy great success, with a steadily increasing number of customers and projects – many of which are late stage development projects preparing for commercial launch. At the same time, we are handling many new and exciting customer projects and give support to processes already running in our facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for Team Leaders with experience in either upstream or downstream processing of biopharmaceuticals. The Process Transfer department is divided into three teams (upstream process transfer, downstream process transfer and process validation), each with 6 scientists to be led by a team leader/manager. We are now looking to appoint the USP team lead and the DSP team lead.The Team Leaders will be responsible for either the upstream or downstream team, responsible for process transfers from customers and/or development. More specifically, the teams facilitate the transfer of processes into and from development to the manufacturing area, ensuring the quality/documentation is in place for manufacturing according to customer and regulatory expectations. The candidates could also be assigned to a part of the project portfolio while managing the team of SME’s.Moreover, the Team Leaders will direct the project related activities focused on process transfer and manufacturing scientific support, through interaction with scientific and technical staff while gathering, analyzing, and interpreting development and manufacturing data as well as compiling the required documentation. This role requires proven scientific and technical skills as either a professional in the field of upstream or downstream sciences, including leadership skills working with a team of professionals. The Team leaders will work closely with and oversee activities of scientific staff and report directly to the department Director of Process Transfer. The team leaders must create a positive, motivating and productive working climate in accordance with AGC Biologics values. Additionally she/he must conduct employee performance appraisals and set goals. The candidate will be responsible for cross-organizational activities associated with the Manufacturing, Quality, and Development organization by reporting of relevant result from the department to stakeholders. The position offer interaction with a large number of stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development and manufacturing. You will be introduced to biopharmaceutical companies globally and be an active player in their projects.  Key responsibilities:

  •  Monitor team member’s participation, engagement, and performance to ensure individual performance in the team setting
  • Communicate clear instructions and feedback to team members and listen to team members' feedback
  • Facilitate and or provide training for team members on a as needed basis
  • Develop team strategy to reach team and department goals
  • Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards
  • Manage the flow of  operations in the team – ability to balance workload over several projects simultaneously
  • Provide innovative solutions to complex problems surrounding the Development and Manufacturing processes - Provide scientific support to Manufacturing on e.g. investigations and provide required documentation for operations in the manufacturing area 
  • Support requests for technical assistance from the rest of the AGC biologics organization globally – ensuring seamless cross-organizational interactions Interfaces with internal and external stakeholders and represent the department and team effectively and professionally
  • Report and update the team´s progress to department manager
  • Design test plans and or protocols, create technical reports and presentations and complete tasks delegated by head of department
  • Assist Head of department in department and scientific efforts as needed.

Your profile:

  •  Degree in science, engineering, or a related field (at least MSc. or PhD level)
  • Several years experience in either upstream or downstream manufacturing and/or upstream or downstream development of biopharmaceuticals in clinical stages, preferably also at commercial production.
  • Leadership experience or strong leadership potential.
  • Excellent English communication and ability to effectively communicate with others engaging with customers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders
  • Familiar with EMA, FDA, and ICH regulations for biologics
  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks.

AGC Biologics CopenhagenAGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will largely be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time. 

Application

We cooperate with Adecco on recruitments. Accordingly Adecco will be responsible for the recruitment process. For more information about the position, please contact Adecco's recruitment team.

 

We continuously evaluate incoming applications and conduct interviews accordingly. Therefore, please submit your application and CV as soon as possible. When the right candidate are found, the ad will close. 

NB. Start date will be latest December, 1st 2020.About AGC BiologicsAGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development.Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing. 


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